AzTrials
AzTrials

Chronic Neck PainNCT06697457

Comparison of the Effectiveness of Different Exercise Types in Individuals with Chronic Neck Pain

A study testing Craniocervical Flexion Exercise Group, Conventional Treatment Group and Dynamic Isometric Exercise Group in people with Chronic Neck Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The aim of this study is to compare the effectiveness of craniocervical flexion, static and dynamic isometric exercise training applied with a conventional physiotherapy program in individuals with chronic neck pain. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Neck Pain
What is being tested?
Craniocervical Flexion Exercise Group, Conventional Treatment Group and Dynamic Isometric Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Jun 2024to Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Being between the ages of 18 and 55,
  • Scoring 15/50 or less on the Neck Disability Index,
  • Having a history of chronic neck pain for at least 3 months,
  • Having a pain level of 5/10 or more,
  • Showing signs of cervical movement control dysfunction,
  • Having cervical muscle tenderness during physical examination.

Who cannot join

  • Being diagnosed with a vascular disease,
  • Being diagnosed with a vestibular disease,
  • Being diagnosed with hypertension,
  • Being diagnosed with fibromyalgia or rheumatoid arthritis,
  • Having had spine surgery in the last 12 months,
  • Having received an exercise program or standard physiotherapy program involving the cervical region in the last 12 months,
Show all 9Show fewer
  • Having congenital or acquired kyphosis, scoliosis, etc. having postural deformity,
  • Having specific neck pain such as cancer,
  • Having fractures, instability, inflammatory diseases, history of neck trauma, infections, neurological deficit, having spinal diseases such as radiculopathy, spondylosis.

Trial locations and contacts

1 site in 1 country.

Ayşen Canan Pakeloğlu, Physiotherapist contact

+905059102642

aysencanan95@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Mugla Education and Research Hospital

    Muğla, Menteşe, 48000

    Ayşen Canan Pakeloğlu, Physiotherapist, +905059102642, aysencanan95@gmail.com

    Ayşen Canan Pakeloğlu, Physiotherapist

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effectiveness of Dynamic Isometric, Static Isometric and Craniocervical Flexor Exercise Training in Individuals with Chronic Neck Pain

The aim of this study is to compare the effectiveness of craniocervical flexion, static and dynamic isometric exercise training applied with a conventional physiotherapy program in individuals with chronic neck pain.

Read the detailed description

Neck pain is a significant musculoskeletal problem that is frequently encountered in society. Pain that cannot be diagnosed with a specific pathology is called "nonspecific" and pain that continues for more than three months is called "chronic pain". Chronic nonspecific neck pain has negative effects on function and quality of life. The importance of the exercise approach in the treatment of neck pain is quite great. Craniocervical flexion and static isometric exercises are frequently used in individuals with chronic neck pain. However, there are very few studies that include dynamic isometric exercises. The aim of this study is to compare the effectiveness of craniocervical flexion, static and dynamic isometric exercise training applied with a conventional physiotherapy program in individuals with chronic neck pain. The intervention groups of the study are deep cervical flexion exercise training, dynamic isometric exercise training and static isometric exercise training and electrotherapy group. The craniocervical flexion exercise training group will receive deep cervical flexor muscle training with Pressure Biofeedback, the dynamic isometric exercise group will receive exercise training with Thera-band, and the static isometric exercise group will receive neck isometric exercises. The electrotherapy group will receive hotpack, tens, and ultrasound applications. At the beginning and end of the study, pain, disability, posture, muscle strength, endurance, range of motion, and body awareness will be assessed in all individuals.TENS (Transcutaneous Electrical Nerve Stimulation) will be applied to all groups for 20 minutes with a TENS device at a strength of 10-30 mA and a frequency of 80 Hz. A pair of surface electrodes will be placed on the painful area of the neck. The intensity of TENS will be adjusted according to the patient's sensory thresholds so that they are not disturbed by a numbness sensation. After TENS, continuous ultrasound will be applied to the cervical region to produce thermal effects. The intensity will be 1.5 W/cm² and the duration will be 5 minutes. Hotpack will be applied to the trapezius muscle for 10 minutes. Chin tuck exercise will be applied to the cervical region.

Being tested
Craniocervical Flexion Exercise Group, Conventional Treatment Group, Dynamic Isometric Exercise Group, Static Isometric Exercise Group
Keywords
neck pain, chronic, exercise
Medical subject headings
Neck Pain, Bronchiolitis Obliterans Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Craniocervical Flexion Exercise GroupOther

    The patient will first be taught to contract the deep cervical flexors. Patients will be placed in a supine position (without a pillow) to ensure a neutral neck position. Patients will be asked to perform slow, controlled head and upper cervical flexion by bringing the chin closer to the chest ("yes" movement). The stabilizer will be inflated to 20 mmHg. Gradual training will be given to increase the pressure value by 2 mmHg between 20 and 30 mmHg. Each pressure value (22, 24, 26, 28 mmHg) will be held for 10 seconds and repeated 10 times. The exercise will be performed with 10 repetitions, 10 seconds of contraction and 5 seconds of relaxation. Exercise training will begin with 20 mmHg and once the patient can hold it for 10 seconds with 10 repetitions, the next level on the pressure stabilizer will be moved on.Treatments will be performed 3 days a week for 8 weeks.

  • Conventional Treatment GroupOther

    TENS will be applied with a TENS device at an intensity of 10-30 mA and a frequency of 80 Hz for 20 minutes. A pair of surface electrodes will be placed on the painful area of the neck. The intensity of TENS will be adjusted according to the patient's sensory thresholds so that the patient is not disturbed by a numb feeling. After TENS, continuous ultrasound will be applied to the cervical region to produce thermal effects. The intensity will be 1.5 W/cm² and the duration will be 5 minutes. Hotpack will be applied to the trapezius muscle for 10 minutes. Chin tuck exercise will be applied to the cervical region.Treatments will be performed 3 days a week for 8 weeks.

  • Dynamic Isometric Exercise GroupOther

    The exercises will be performed by the patient with an elastic band. The progression of the exercises will be performed using different colors of Thera-bands with different resistances. It will start with the red Thera-band with the lowest resistance and then move on to the green and then blue Thera-bands with increasing resistance. Cervical isometric exercises will be performed with elastic resistance bands, maintaining the chin tuck position, forward, backward, crosswise, right and left. There will be 10 repetitions for 10 seconds for each. Progression in Therabands will be according to the patient. When the patient does 10 repetitions for 10 seconds, the next Theraband will be used.Treatments will be performed 3 days a week for 8 weeks.

  • Static Isometric Exercise GroupOther

    The patient will perform isometric exercises with maximal effort against neck flexion, extension, lateral flexion and rotation with his/her hand in a sitting position. Each exercise will be performed for 10 seconds, with 15-second breaks in between, for 10 repetitions. Each patient will start with submaximal resistance to help them adapt to isometric exercises, and then progress will be checked until the patient reaches the maximum resistance that can be tolerated by each session. It will consist of cervical flexion, cervical extension, right lateral flexion, left lateral flexion, right rotation, left rotation exercises. Progress in the exercises will be according to the Rating of Perceived Exertion Borg (RPE) Scale according to the weeks.Treatments will be performed 3 days a week for 8 weeks.

Study groups in NCT06697457
Study groupRoleWhat they receive
Conventional TreatmentActive comparatorConventional treatment will include electrotherapy agents (TENS, ultrasound and hotpack) and chin tuck posture exercises.
Receives: Other: Conventional Treatment Group
Craniocervical Flexion Exercise TrainingActive comparatorPatients will receive exercise in addition to conventional treatment. The exercises will be performed with an air-filled pressure stabilizer placed in the sub-occipital region.
Receives: Other: Craniocervical Flexion Exercise Group; Other: Conventional Treatment Group
Dynamic Isometric Exercise TrainingActive comparatorPatients will receive exercise in addition to conventional treatment. The exercises will be performed by the patient with an elastic band.
Receives: Other: Conventional Treatment Group; Other: Dynamic Isometric Exercise Group
Static Isometric Exercise TrainingActive comparatorPatients will receive exercise in addition to conventional treatment. The patient will perform isometric exercises with maximal effort against neck flexion, extension, lateral flexion and rotation with his/her hand in a sitting position.
Receives: Other: Conventional Treatment Group; Other: Static Isometric Exercise Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Assesment

    The assessment will be made with Visual Analogue Scale (VAS) and algometer. VAS is considered both valid and reliable in measuring the pain intensity of patients. Each participant will be asked to indicate the intensity of pain they have experienced in the previous 24 hours. This will be done by marking on a 10 cm line where "0" is "No Pain" and "10" is "Maximum Pain".

    Measured: 8 week

  2. Pain Assesment

    An algometer with a 1 cm2 rounded surface area will be used for objective pain assessment. Measurements will be made on the spinous processes of C2 and c5 and the trapezius muscle. The assessor will gradually increase the pressure until pain or discomfort occurs and the patient says "yes". The average of the three measurements will be taken. A 30-second rest period will be given between each measurement.

    Measured: 8 week

  3. Disability Assesment

    Neck Disability Index, designed to assess how neck pain affects daily living activities, will be used. The questionnaire includes 10 items that measure disability secondary to neck pain. Scores range from 0-50 and are interpreted as follows:

    • 0-4 represents no disability,
    • 5-14 represents mild disability,
    • 15-24 represents moderate disability,
    • 25-33 represents severe disability,
    • 34 and above represents complete disability.

    Measured: 8 week

Secondary outcomes (8)
  1. Cervical Joint Range of Motion Assessment

    Goniometer will be used for active ROM (flexion, extension, left/right rotation, left/right lateral flexion) measurements. Maximum ROM will be measured in degrees for each test. Participants will be asked to sit against the back of the chair, look forward, and position their arms in a relaxed manner.

    Measured: 8 week

  2. Cervical Postur Assesment

    Tragus Wall Distance Measurement will be performed with 2-3 practical trials to ensure that the participant has taken the correct posture. After the posture is appropriate, the tragus wall distance will be measured with a millimeter ruler while the participants stand naturally and perform cervical retraction

    Measured: 8 week

  3. Cervical Postur Assesment

    The craniovertebral angle will be measured for forward head posture in the sagittal plane. The craniovertebral angle will be measured with the photograph method. The camera is fixed 1.5 meters away on a flat surface aligned with the humeral head of the participants. The participants are asked to perform head flexion-extension movements to find the neutral head position and the participants are told to stay in the most appropriate position. A cursor is placed on the c7 spinous process and tragus in the photograph. The participants' photographs are taken 3 times. Craniovertebral angle is measured with the photographs taken and noted in degrees. The angles are averaged. Image processing will be done with Image J software

    Measured: 8 week

  4. Cervical Strength Assessment

    Hand Held dynamometer will be used for strength assessment. It will include 3 isometric contractions held for 3 seconds for flexion, extension, lateral flexion and rotation movements. The value greater than the maximal contractions will be recorded.

    Measured: 8 week

  5. Cervical Endurance Assessment

    In the Craniocervical Flexion Test, participants will be in a supine position and the compressed air unit will be placed behind the cervical spine, just below the occiput. It will be inflated to 20 mmHg initially and participants will be instructed to perform the craniocervical flexion movement. Thus, the pressure will increase to 22 mmHg and they will be asked to maintain this position for 10 seconds. Then, a 30-second rest period will be given and the entire procedure will be repeated for 24, 26, 28 and 30 mmHg. The final reading will be taken when the participant cannot hold the specific pressure for 10 seconds. Before the test, participants will be given enough time to practice.

    Measured: 8 week

  6. Cervical Endurance Assesment

    Cervical Flexion Endurance Test: Participants will be asked to lie in a crook-lying position. The physiotherapist will place their hand under the patient's head. They will be asked to lift their head approximately 2.5 cm off the bed and maintain this position for as long as possible. The test will end when the patient feels any pain or fatigue or when their head touches the therapist's hand. Endurance time was measured in seconds. The test will be performed twice with 3 minutes of rest between repetitions.

    Measured: 8 week

  7. Cervical Endurance Assessment

    Cervical Extensor Endurance Test: For the test, patients will be asked to lie in a prone position with their head and upper body positioned on the edge of the bed and their arms next to their body. A 2 kg sandbag will be placed on the patient's cervical region. They will then be asked to lift their head to a neutral position and maintain this position. The test will end when the patient feels any pain or fatigue or when there is a 5° deterioration in head position (measured with an inclinometer). The test will be repeated twice with a 3-minute rest interval and the longest holding time in seconds will be recorded as the test result.

    Measured: 8 week

  8. Neck Awareness Assesment

    It will be evaluated with the Fremantle Neck Awareness Questionnaire. It is a simple Likert-type questionnaire (0=Never/Never feel like this, 1= Rarely feel like this, 2= Sometimes or some of the time feel like this, 3= Often feel like this, 4= Always or most of the time feel like this) that evaluates the individual's altered perception. The questionnaire asks individuals 9 questions such as how they perceive their neck in relation to their body.

    Measured: 8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2024
  2. Study start24 Jun 2024
  3. Primary completionJan 2025 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Four groups, parallel, randomized controlled
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06697457
Sponsor's protocol ID
MSKU-FTR-ACP-01
Status last verified
Jun 2024
First submitted
18 Nov 2024
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Craniocervical Flexion Exercise Group, Conventional Treatment Group and Dynamic Isometric Exercise Group in people with Chronic Neck Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ayşen Canan Pakeloğlu, Physiotherapist (+905059102642, aysencanan95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Assesment (time frame: 8 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in